CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials
Authors: Kenneth F. Schulz, Douglas G. Altman, David Moher
Journal: Annals of Internal Medicine (2011)

Letters15 February 2011CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized TrialsKenneth F. Schulz, PhD, MBA, Douglas G. Altman, DSc, and David Moher, PhDKenneth F. Schulz, PhD, MBAFrom Family Health International, Research Triangle Park, NC 27709; University of Oxford, Oxford, OX2 6UD, United Kingdom; and University of Ottawa, Ottawa K1N 6N5, Canada., Douglas G. Altman, DScFrom Family Health International, Research Triangle Park, NC 27709; University of Oxford, Oxford, OX2 6UD, United Kingdom; and University of Ottawa, Ottawa K1N 6N5, Canada., and David Moher, PhDFrom Family Health International, Research Triangle Park, NC 27709; University of Oxford, Oxford, OX2 6UD, United Kingdom; and University of Ottawa, Ottawa K1N 6N5, Canada.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-154-4-201102150-00017 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:Golomb and colleagues (1) write that in CONSORT 2010, “there is no requirement to stipulate the composition of the putative placebo or the inactive elements of the test treatment.” To the contrary, these are definitively “interventions” in CONSORT 2010, which explicitly requests a description of “the interventions for each group with sufficient details to allow replication” (2). To satisfy that replication criterion, the composition of the placebo or inactive elements would have to be described. Nevertheless, we appreciate that Golomb and colleagues have highlighted this issue. We should clarify our position and use their paper as a reference ...References1. Golomb BA, Erickson LC, Koperski S, Sack D, Enkin M, Howick J. What's in placebos: who knows? Analysis of randomized, controlled trials. Ann Intern Med. 2010;153:532-5. [PMID: 20956710] LinkGoogle Scholar2. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. [PMID: 20332509] CrossrefMedlineGoogle Scholar3. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. [PMID: 20332511] CrossrefMedlineGoogle Scholar4. Schulz KF, Altman DG, Moher D, Fergusson D. CONSORT 2010 changes and testing blindness in RCTs. Lancet. 2010;375:1144-6. [PMID: 20338625] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Kenneth F. Schulz, PhD, MBA; Douglas G. Altman, DSc; David Moher, PhDAffiliations: From Family Health International, Research Triangle Park, NC 27709; University of Oxford, Oxford, OX2 6UD, United Kingdom; and University of Ottawa, Ottawa K1N 6N5, Canada.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-0379. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoCONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials Kenneth F. Schulz , Douglas G. Altman , and David Moher , for the CONSORT Group* What's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials Beatrice A. Golomb , Laura C. 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A Systematic Review with Meta-analysis and Moderator Analysis 15 February 2011Volume 154, Issue 4Page: 291-292KeywordsBlindnessConflicts of interestDisclosureRandomized trialsReasoning ePublished: 15 February 2011 Issue Published: 15 February 2011 Copyright & PermissionsCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...